The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is: What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis? Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit. No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.
Study Type
OBSERVATIONAL
Enrollment
40,000
Participants will be offered finger-stick point-of-care testing for HCV
ACT Justice Health
Canberra, Australian Capital Territory, Australia
NOT_YET_RECRUITINGJustice Health and Forensic Mental Health Network
Sydney, New South Wales, Australia
RECRUITINGQueensland Injectors Health Network Ltd
Bowen Hills, Queensland, Australia
ACTIVE_NOT_RECRUITINGWest Moreton Hospital and Health Service
Brisbane, Queensland, Australia
RECRUITINGLotus Glen Correctional Centre
Cairns, Queensland, Australia
RECRUITINGTownsville Correctional Centre
Townsville, Queensland, Australia
NOT_YET_RECRUITINGWoodford Correctional Centre
Woodford, Queensland, Australia
RECRUITINGSouth Australian Prison Health Service
Adelaide, South Australia, Australia
NOT_YET_RECRUITINGHepatitis South Australia
Hackney, South Australia, Australia
NOT_YET_RECRUITINGTasmanian Prison Service
Hobart, Tasmania, Australia
NOT_YET_RECRUITING...and 2 more locations
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.
HCV treatment
Time frame: 12 weeks from enrolment
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Accepting testing
Time frame: Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Prevalence
Time frame: Recruitment phase
To evaluate the HCV antibody prevalence among people tested.
Prevalence
Time frame: Recruitment phase
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Time to treatment
Time frame: 52 weeks
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
Initiation of treatment
Time frame: 52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Completion of treatment
Time frame: 52 weeks
To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment
SVR
Time frame: 52 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
HCV negative
Time frame: 52 weeks
To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.
Cost-effectiveness
Time frame: 52 weeks
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